Industry Training for Medical Device Manufacturers

Application of Agile to the Development of Medical Device Systems

For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile's Lean Product Development principles also apply to the development of hardware-based products and systems. This 2½-day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be used in the development of medical device systems.

Applying Human Factors to Improve Instructional Materials as Part of the User Interface

This 2-day course will provide participants with a process and methodology for those involved in the design, development and human factors testing of instructional materials for medical device users that is consistent with industry standards and guidelines including FDA, the AAMI 3-Day Human Factors Workshop and AAMI TIR 49. Faculty with a combined 58 years of experience skillfully lead participants through case studies and interactive exercises creating a dynamic and high immersion environment resulting in real skill development.

This 2-day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and/or validating actions; how to write good CAPA plans; how risk management is used in conjunction with the CAPA system; and 21 CFR and ISO 13485 requirements.

Design Control Requirements and Industry Practice

This intensive 2½-day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. The content focuses on the how-to's of implementing a program that meets FDA's design control requirements while ensuring a fast and efficient flow of new products.

Effective Application of Agile Practices in the Development of Medical Device Software

Upon completion of this 2-day course, participants will be able to evaluate the challenges with the use of Agile practices and be prepared to adapt these practices as needed to ensure the development of compliant, safe, and effective products. This course builds on the concepts in AAMI TIR45:2012, Guidance on the use of agile practices in the development of medical device software.

Human Factors for Medical Devices

This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

Applying Human Factors to Improve Instructional Materials as Part of the User Interface

This 2-day course will provide participants with a process and methodology for those involved in the design, development and human factors testing of instructional materials for medical device users that is consistent with industry standards and guidelines including FDA, the AAMI 3-Day Human Factors Workshop and AAMI TIR 49. Faculty with a combined 58 years of experience skillfully lead participants through case studies and interactive exercises creating a dynamic and high immersion environment resulting in real skill development.

Ethylene Oxide Sterilization for Medical Devices

This highly interactive 3½-day, advanced course assumes that participants are experienced in working with an established ethylene oxide sterilization process, but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The program combines classroom lecture with real-life scenarios to illustrate concepts and situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. Some of the topics to be covered are: validation and requalification; validation reports, protocols, and documentation; product adoption; troubleshooting; process changes and process equivalency; product release methods; and optimization of sterilization process.

Integrating Risk Management into the Quality System

This comprehensive 2½-day course for medical device manufacturers presents risk management concepts used throughout the quality system as well as the lifecycle of the product, from design…to manufacturing…through post-production.

Process Validation Requirements and Industry Practice

This 2½-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples.

Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation Post-Course Test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System regulation. This optional post-test which is available online for 2 weeks following the end of the program, will be available to all participants.

Purchasing Controls and Supply Chain Management

This 2½-day course provides extensive information on effective implementation of supplier selection and controls. This detailed course covers the key aspects of supplier controls, from planning for supplier assessment/selection, to defining acceptance activities, to monitoring supplier performance. Each topic is presented from a practical perspective, with links to the requirements of the Quality System Regulation, the ISO 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidance.

The course also covers life-cycle management approaches for a medical device manufacturing organization's supply chain. The course includes substantial "hands-on" exercises to allow attendees to apply concepts and interact with colleagues, and provides specific industry examples.

The regulatory world for quality management systems (QMS) is changing fast. To succeed in today’s global market, the manufacturers of medical devices must understand those requirements. This intensive 4½-day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices­­-Application of risk management to medical devices.

Regulatory Requirements for Software Validation

This 3-day course focuses on the requirements contained in the Quality System regulation specific to software validation. The course explores the latitude and flexibility of the FDA's expectations and provides conceptual ways to meet compliance requirements. Relevant standards, FDA guidance documents, and other resources will be discussed that assist in determining compliance practices.

Risk Management & Human Factors

This advanced 1½-day course is beneficial for understanding both the expectations of the FDA as well as the best practices for human factors risk management. Participants will learn how to incorporate risk management activities into their human factors planning.